GSK's Ph III Entereg trial completes enrollment

UK drug major GlaxoSmithKline has completed enrollment of a Phase III clinical program to evaluate the efficacy and safety of its oral investigational drug Entereg (alvimopan; co-developed with Adolor Corp) for the treatment of gastrointestinal adverse events caused by opioids used for persistent non-cancer pain. Enrollment of a Phase IIb study in cancer patients with persistent pain has also been completed, the firm noted.

The Phase III international, multicenter program includes two efficacy-safety studies and one long-term safety study. GSK completed the enrollment earlier than anticipated and the companies are targeting the submission of a New Drug Application and Marketing Authorization Application filing in the middle of next year.

Yvonne Greenstreet, senior vice president of GSK's Medicine Development Centre welcomed the end of recruitment ahead of schedule as a sign of unmet medical need in this patient population. The firms noted that the Phase III international, randomized, double-blind, placebo-controlled efficacy studies are both designed to enroll approximately 480 adults and are intended to assess Entereg's efficacy against GI side effects associated with opoid-induced bowel dysfunction. Both trials will employ frequency of spontaneous bowel movements as their primary endpoint.